Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 9 the comma should be deleted.
Appropriate correction is respectfully requested.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“receiver module”, “optimizer” “steering module”, “electrode removal module”, “adjusting module”, “scoring module”, “candidate module” in claim 1 and “voxel calculation module” in claim 11.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recites sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "each of the electrodes" in lines 10-11. It is unclear whether the limitation “each of the electrodes” is referring to “a plurality of electrodes” in line 2 or a different set of electrodes altogether. For the purposes of examination, it will be interpreted as being the same plurality of electrodes.
Claim 14 recites the limitation "each of the electrodes" in line 8. It is unclear whether the limitation “each of the electrodes” is referring to “a plurality of electrodes” in line 2 or a different set of electrodes altogether. For the purposes of examination, it will be interpreted as being the same plurality of electrodes.
10. Claims 2-13 and 15-20 are rejected at least because they depend from a claim(s) which is indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 and 14-20 are rejected under 35 U.S.C 103 as being unpatentable over Kashyap et al. (US Pub.: 2020/0391040 A1) and further in view of Wechter et al. (US Pub.: 2017/0165490 A1).
Regarding claim 1, Kashyap teaches a configuration system (e.g. Fig. 3 – neuromodulation device 312) for configuring delivery of neuromodulation to specific tissue of a patient by an implantable system having a plurality of electrodes (e.g. paragraphs 0069, 0071), the configuration system (312) comprising: a receiver module (e.g. paragraph 0071 – sensing circuitry) configured to receive at least patient data for a patient and lead position indicating a location of a lead (e.g. Fig. 3 – lead system 317; paragraph 0071)
carrying at least two of the plurality of electrodes (e.g. Fig. 3 – plurality of electrodes 311-1 to 311-N) thereon relative to neural tissue of the patient (e.g. paragraphs 0071, 0148);
an optimizer (e.g. Fig. 19 – programmer device 1920)
for identifying candidate therapy parameter sets indicating utilization of the plurality of electrodes during therapy (e.g. paragraphs 0151, 0163),
the optimizer (1920) comprising:
a steering module (e.g. Fig. 21 – field sensor analyzer 2108)
for identifying a potential fractionalization to analyze, the potential fractionalization setting proportions of total current to be issued by each of the electrodes (e.g. paragraphs 0147-0148);
an adjusting module (e.g. Fig. 21 – electrode energy fractionalizer 2102)
that receives the reduced fractionalization and creates an adjusted fractionalization (e.g. paragraphs 0146, 0149);
a scoring module (e.g. Fig. 20 – weighting control 2008)
that receives the adjusted fractionalization and calculates a plurality of metrics for the adjusted fractionalization using a plurality of amplitude settings (e.g. paragraphs 0137-0138); and
a candidate module (e.g. Fig. 22 – supervisor engine 1906)
that identifies one or more candidate therapies using the plurality of metrics (e.g. paragraphs 0151-0152).
However, Kashyap does not explicitly teach an electrode removal module that receives the potential fractionalization and removes unavailable electrodes from the potential fractionalization to generate a reduced fractionalization.
Wechter, in a same field of endeavor of neurostimulation systems, discloses an electrode removal module (e.g. Fig.6 – controller 650) that receives the potential fractionalization and removes unavailable electrodes from the potential fractionalization to generate a reduced fractionalization (e.g. paragraphs 0025, 0061).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kashyap to incorporate an electrode removal module that receives the potential fractionalization and removes unavailable electrodes from the potential fractionalization to generate a reduced fractionalization, as taught and suggested by Wechter, in order to reduce the power consumption of the implantable neurostimulator and thereby increasing its battery life (Wechter, paragraph 0025).
Regarding claim 2, Kashyap in view of Wechter teaches the configuration system of claim 1 as discussed above, and Kashyap further teaches wherein the optimizer (1920) is configured to use the steering module (2108) to identify a plurality of potential fractionalizations (e.g. paragraphs 0147-0148).
Regarding claim 3, Kashyap in view of Wechter teaches the configuration system of claim 1 as discussed above, and Kashyap further teaches wherein the potential fractionalization identifies active and inactive electrodes (e.g. paragraphs 0111, 0150), and the adjusting module (2102) creates the adjusted fractionalization by proportionally increasing a fraction of current to be delivered by each active electrode which is not removed by the electrode removal module (e.g. paragraphs 0146, 0149).
Regarding claim 4, Kashyap in view of Wechter teaches the configuration system of claim 1 as discussed above, and Kashyap further teaches wherein the potential fractionalization identifies active and inactive electrodes (e.g. paragraphs 0111, 0150), and the adjusting module (2102) modifies current fractionalization by adding current to active electrodes in proportion to proximity to the unavailable electrodes (e.g. paragraphs 0149, 0152).
Regarding claim 5, Kashyap in view of Wechter teaches the configuration system of claim 4 as discussed above, and Kashyap further teaches wherein the proportion is based on a Gaussian curve (e.g. paragraph 0134).
Regarding claim 6, Kashyap in view of Wechter teaches the configuration system of claim 1 as discussed above, and Wechter further teaches wherein the electrode removal module (650) removes electrodes having an impedance outside of an impedance range (e.g. paragraph 0063).
Regarding claim 7, Kashyap in view of Wechter teaches the configuration system of claim 1 as discussed above, and Wechter further teaches wherein the electrode removal module (650) removes electrodes that have been identified as unavailable by a physician (e.g. paragraphs 0024-0025).
Regarding claim 8, Kashyap in view of Wechter teaches the configuration system of claim 7 as discussed above, and Wechter further teaches wherein the electrode removal module (650) is configured to identify an electrode that could be removed by identifying proximity to a neural structure less than a threshold proximity, and suggesting electrode removal to a physician via a user interface (e.g. paragraphs 0027, 0054).
Regarding claim 9, Kashyap in view of Wechter teaches the configuration system of claim 7 as discussed above, and Wechter further teaches wherein the electrode removal module (650) is configured to identify an electrode that could be removed by identifying an electrode having an impedance outside of an impedance range, and suggesting electrode removal to a physician via a user interface (e.g. paragraphs 0024, 0054).
Regarding claim 14, Kashyap teaches a method of operation in a neuromodulation system (e.g. Fig 2 – neuromodulation system 212; paragraph 0069),
the neuromodulation system including an implantable system (e.g. paragraph 0069) having a plurality of electrodes (e.g. Fig. 3 – plurality of electrodes 311-1 to 311-N; paragraph 0069),
and a configuration system (e.g. Fig. 3 – neuromodulation device 312) configured to perform steps of the method (e.g. paragraph 0069), the method comprising:
a) receiving at least patient data for a patient and a lead position indicating a location of a lead carrying at least two of the plurality of electrodes thereon relative to neural tissue of the patient (e.g. paragraph 0071);
b) identifying a potential fractionalization to analyze, the potential fractionalization setting proportions of total current to be issued by each of the electrodes (e.g. paragraphs 0147-0148);
d) adjusting the reduced fractionalization to create an adjusted fractionalization (e.g. paragraphs 0146, 0149);
e) calculating a plurality of metrics for the adjusted fractionalization using a plurality of amplitude settings (e.g. paragraphs 0137-0138); and identifying one or more of the adjusted fractionalizations as one or more candidate therapies using the plurality of metrics (e.g. paragraphs 0151-0152).
However, Kashyap does not explicitly teach c) removing unavailable electrodes from the potential fractionalization to generate a reduced fractionalization.
Wechter, in a same field of endeavor of neurostimulation methods, discloses removing unavailable electrodes from the potential fractionalization to generate a reduced fractionalization (e.g. paragraphs 0025, 0061).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kashyap to incorporate removing unavailable electrodes from the potential fractionalization to generate a reduced fractionalization, as taught and suggested by Wechter, in order to reduce the power consumption of the implantable neurostimulator and thereby increasing its battery life (Wechter, paragraph 0025).
Regarding claim 15, Kashyap in view of Wechter teaches the method of claim 14 as discussed above, and Kashyap further teaches further comprising communicating the one or more candidate therapies from the configuration system to a pulse generator (e.g. Fig. 3 – neuromodulation output circuit 315 + neuromodulation circuit 316) for the implantable system (e.g. paragraph 0069), and activating the pulse generator (315+316) to issue neuromodulation to the patient using at least one of the one or more candidate therapies (e.g. paragraphs 0071, 0151).
Regarding claim 16, Kashyap in view of Wechter teaches the method of claim 14 as discussed above, and Kashyap further teaches further comprising identifying a plurality of potential fractionalizations, and performing each of c), d) and e) for each of the plurality of potential fractionalizations (e.g. paragraphs 0147-0148).
Regarding claim 17, Kashyap in view of Wechter teaches the method of claim 14 as discussed above, and Kashyap further teaches wherein the potential fractionalization identifies active and inactive electrodes (e.g. paragraphs 0111, 0150), and step d) includes proportionally increasing a fraction of current to be delivered by each active electrode which is has not removed during step c) (e.g. paragraphs 0146, 0149).
Regarding claim 18, Kashyap in view of Wechter teaches the method of claim 14 as discussed above, and Kashyap further teaches wherein the potential fractionalization identifies active and inactive electrodes (e.g. paragraphs 0111, 0150), and step d) include increasing proportions of total current to be issued by each of the electrodes in proportion to proximity to the unavailable electrodes (e.g. paragraphs 0149, 0152).
Regarding claim 19, Kashyap in view of Wechter teaches the method of claim 14 as discussed above, and Wechter further teaches wherein step c) includes removing electrodes having an impedance outside of an impedance range (e.g. paragraph 0063).
Regarding claim 20, Kashyap in view of Wechter teaches the method of claim 14 as discussed above, and Wechter further teaches wherein step c) includes removing electrodes that have been identified as unavailable by a physician (e.g. paragraphs 0024-0025).
Claims 10-13 are rejected under 35 U.S.C 103 as being unpatentable over Kashyap and further in view of Wechter and further in view of Mustakos et al. (US Pub.: 2019/0184171 A1).
Regarding claim 10, Kashyap in view of Wechter teaches the configuration system of claim 1 as discussed above. However, Kashyap in view of Wechter does not explicitly teach further comprising a voxel calculation module which identifies volumes located around the lead as voxels, and labels at least some voxels as target voxels to which therapy is to be directed.
Mustakos, in a same field of endeavor of neurostimulation systems, discloses further comprising a voxel calculation module (e.g. Fig. 10A – metric value optimization circuit 1010) which identifies volumes located around the lead as voxels, and labels at least some voxels as target voxels to which therapy is to be directed (e.g. paragraphs 0079, 0099).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kashyap and Wechter to incorporate a voxel calculation module which identifies volumes located around the lead as voxels, and labels at least some voxels as target voxels to which therapy is to be directed, as taught and suggested by Wechter, for the purpose of providing more customized therapy to the patient and increasing therapeutic benefits (Mustakos, paragraph 0080).
Regarding claim 11, Kashyap in view of Wechter in view of Mustakos teaches the configuration system of claim 10 as discussed above, and Mustakos further teaches wherein the voxel calculation module (1010) also labels at least some voxels as avoid voxels to which therapy is to be avoided (e.g. paragraph 0079).
Regarding claim 12, Kashyap in view of Wechter in view of Mustakos teaches the configuration system of claim 10 as discussed above, and Mustakos further teaches wherein the scoring module calculates the plurality of metrics by determining which of the voxels would be activated by the adjusted fractionalization at a plurality of current amplitudes (e.g. paragraphs 0103, 0110).
Regarding claim 13, Kashyap in view of Wechter in view of Mustakos teaches the configuration system of claim 10 as discussed above, and Mustakos further teaches wherein the scoring module uses one or more of a weight for target voxels, a weight for avoid voxels, a weight for total activated voxels and/or a weight for total activated non-target and non-avoid voxels to calculate the metrics (e.g. paragraphs 0079-0080).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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